Ofloxacin Otic
- Product NDC
- 53002-2604
- 11-digit product format
- 530022604
- Labeler code
- 53002
- Product ID
- 53002-2604_90f6aff2-4d88-4e2f-bb40-7f4c9f7ccf2a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ofloxacin
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA076527
- Marketing category
- ANDA
- Marketing start
- 2004-05-14
- Marketing end
- 0000-00-00
- Substance
- OFLOXACIN
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC],Quinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-2604-1 | Ofloxacin Otic | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-2604 | OFLOXACIN OTIC (OFLOXACIN) SOLUTION [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_7592cf3f-7d4b-436f-89f0-a3686570fef8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-2604-1 | 53002260401 | 5 mL in 1 BOTTLE, DROPPER (53002-2604-1) | 5 ml | 2018-10-01 | 0000-00-00 | No | No | Current |